IMPLANT FOR BONE SEGMENT FUSION
20210022873 ยท 2021-01-28
Inventors
Cpc classification
A61F2310/00023
HUMAN NECESSITIES
A61B17/7032
HUMAN NECESSITIES
A61F2/30771
HUMAN NECESSITIES
A61F2002/3085
HUMAN NECESSITIES
A61F2310/00796
HUMAN NECESSITIES
A61F2002/30863
HUMAN NECESSITIES
A61B17/7098
HUMAN NECESSITIES
A61F2002/3092
HUMAN NECESSITIES
A61F2002/30622
HUMAN NECESSITIES
A61F2/30988
HUMAN NECESSITIES
A61L2430/02
HUMAN NECESSITIES
C22C27/02
CHEMISTRY; METALLURGY
A61B17/863
HUMAN NECESSITIES
A61B17/8645
HUMAN NECESSITIES
International classification
Abstract
A bone screw implant is provided for immobilizing the articular surfaces of two bone segments by securing, fusing, or compression the two segments. The implant may be fabricated from a porous biocompatible metal and have a cylindrical shape and fully or partially threaded and may have variable pitch threads and a variable diameter of the shaft. The implant may include a blunt tip or a fluted self-drilling tip and a headless screwdriver socket. Large pitch cancellous threads may be in the leading-end portion of the cylinder shaft, and smaller pitch cortical threads may be at the trailing edge portion of the shaft. The implant may be fenestrated, it may have a roughened surface, and it may be coated with an osteoconductive material. The implant may be cannulated. In a specific embodiment, the implant is used for immobilizing the articular surfaces of a sacroiliac joint.
Claims
1. An implant for bone fusion or fixation, comprising a. A cylindrical threaded implant fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to the bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 m and a porosity of 60-65%; b. wherein the shaft (120) of the cylinder of the implant has a diameter between 4 mm to 14 mm and length between 10 mm to 280 mm; c. wherein the implant has a distal section (122) with a distal end (125); d. wherein the implant has a headless proximal section (123) and a proximal end (150) having a socket (152) for attachment to a tool that can rotate to screw the implant into place; e. wherein the implant is threaded with large pitch cancellous helical threads (142) on a portion of the shaft (120), or smaller pitch cortical helical threads (144) on a portion of shaft (123), or wherein the implant has uniform threads (
2. The implant according to claim 1, further comprising threads along the entire length of the implant.
3. The implant according to claim 1, further comprising a central section having no threads on the shaft.
4. The implant according to claim 1, wherein the implant has large pitch cancellous helical threads (142) on the shaft on a portion of the distal section, and smaller pitch cortical helical threads (144) on the shaft on a portion of the proximal section.
5. The implant according to claim 1, wherein the distal section has large pitch cancellous threads, the proximal section has smaller pitch cortical threads, and the proximal section has a flare (154).
6. The implant according to claim 1, wherein the shaft in the section with cancellous threads (122) has a smaller diameter than the diameter of the shaft in the section with the cortical threads (123), and wherein the maximum diameter of the cancellous threads are slightly smaller than the maximum diameter of the cortical threads.
7. The implant according to claim 1, wherein the implant has a channel (134) through the longitudinal axis with openings at the distal end (130) and proximal end (132) for accepting a guidewire.
8. (canceled)
9. (canceled)
10. The implant according to claim 1, wherein the porous titanium or tantalum metal or alloy has pore sizes of 300 to 400 m.
11. The implant according to claim 1, wherein the porous titanium or tantalum metal or alloy has a pore size of 600 m.
12. The implant according to claim 1, wherein the implant has internal threads (170) for the attachment of an additional device.
13. The implant according to claim 1, wherein the distal end comprises a self-drilling tip (126) with one or more teeth (127).
14. The implant according to claim 1, wherein the distal end comprises a blunt tip (129).
15. (canceled)
16. The implant according to claim 1, wherein the implant is used to immobilize the articular surfaces of a sacroiliac joint.
17. A fusion or fixation implant for immobilizing the articular surfaces of a joint or segment of bone or fracture comprising: a. A cylindrical threaded implant fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to the bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 m and a porosity of 60-65%; b. wherein the shaft of the cylinder of the implant has a diameter between 4 mm to 14 mm and length between 10 mm to 280 mm; c. wherein the implant has a distal section with a fluted distal end (126, 127); d. wherein the implant has a flared headless proximal section (123) and a proximal end (152) having a socket (152) for attachment to a tool that can rotate to screw the implant into place; e. wherein the implant is fully threaded with large pitch cancellous helical threads (142) on the shaft on a portion of the distal section, and smaller pitch cortical helical threads (144) on the shaft on a portion of the proximal section; f. wherein the implant has a central channel (134) longitudinally spanning the entire length; g. wherein a set of secondary female threads (170) is in the central channel adjacent to the socket in the proximal end; h. wherein the implant has one or more fenestrations (160); i. wherein the implant is surface treated to have a roughened surface; and j. wherein the implant is coated with hydroxyapatite (HA) or tri-calcium phosphate (TCP) or both.
18. A fusion or fixation implant for immobilizing the articular surfaces of a joint or segment of bone or fracture comprising: a. A cylindrical threaded implant fabricated from a titanium or tantalum metal or alloy with a similar modulus of elasticity to bone, wherein the titanium or tantalum metal or alloy is a porous material with pore sizes ranging in 100 to 900 m and a porosity of 60-65%; b. wherein the shaft of the cylinder of the implant has a diameter between 4 mm to 14 mm and length between 10 mm to 280 mm; c. wherein the implant has a distal section with a distal end with a rounded tip; d. wherein the implant has a headless proximal section and a proximal end having a socket for attachment to a tool that can rotate to screw the implant into place; e. wherein the implant has uniform cortical helical threads on the entire length of the shaft; f. wherein the implant has a channel through the center with openings at the distal end and proximal end for accepting a guidewire; g. wherein the implant has one or more fenestrations; h. wherein the implant is surface treated to have a roughened surface; and i. wherein the implant is coated with hydroxyapatite (HA) or tri-calcium phosphate (TCP) or both.
19. (canceled)
20. (canceled)
21. The implant of claim 12, wherein a feature with male threads is screwed into the internal female threads (170), wherein the feature is selected from a pedicle screw, an extractor, an inserter, or a cap for the proximal end.
22. The implant of claim 17, wherein a feature with male threads is screwed into the internal female threads (170), wherein the feature is selected from a pedicle screw, an extractor, an inserter, or a cap for the proximal end.
Description
DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
[0050] This invention provides a cylindrical, threaded, porous, coated implant for the fusion, stabilization, or compression of two bone segments. One example is fusion and stabilization of the sacroiliac (SI) joint. In an embodiment, the implant is used for arthrodesis of two bone segments in need of fusion. The implant is fabricated from a biocompatible metal and has the unique combination of features including a fluted or blunt tip, variable or uniform thread pitches, use of a porous material, roughened surface, and a coating with an osteoconductive material. The blunt tip is intended to minimize the risk of injury during implantation and to surrounding soft tissue structures; however, a sharper tip could also be fashioned that would allow for a self-tapping and/or self-drilling capability. The inventive implants are implanted by drilling a bore hole slightly smaller than the largest diameter of the implant and screwing the implant into position with a screwdriver.
[0051] In an embodiment, the implant is made of titanium or tantalum to match the modulus of elasticity of bone and is fully porous with pore sizes ranging in 100 to 900 um (micron) to facilitate in-growth and have a porosity of 60-65% to mimic cancellous bone, which would allow for better osseointegration. In addition, the implant would be either a solid porous implant and/or slotted/fenestrated to allow for graft placement.
[0052] In an embodiment the implant has a diameter of 4 mm to 14 mm and length from 10 mm to 280 mm. In use, a kit may be provided for use in the operating theater with a variety of sizes.
[0053] In an embodiment, all surfaces of the implant are roughened with a macro surface roughness which may be accomplished with a technique such as grit blasting, acid etching, or plasma spray coating (also called thermal spray coating).
[0054] In an embodiment, all surfaces of the implant are coated with hydroxyapatite (HA) and/or tricalcium phosphate (TCP), with a coating thickness of approximately 35 m (range 15-50 m). Both HA and TCP are osteoconductive materials that encourage bone growth.
[0055] In an embodiment of the present invention, the implant is cannulated to allow for insertion via a guidewire.
[0056] The implant is either fully threaded as shown on
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[0058] As used herein, the distal and proximal descriptors are in relation to the surgeon implanting the device. Thus, the nose (or tip) end (125) is distal to the surgeon during implantation. This distal end is also referred to as a tip, the front, nose, or leading end. The back end 150 with the screwdriver socket (152) is closer to the surgeon and is therefore the proximal end. The inventive implants have a longitudinal axis running from the nose end 125 to the back end 150. This is illustrated as line A-A in
[0059] As shown in
[0060] In the embodiment 100 illustrated in
[0061] In the embodiment illustrated in
[0062] In the embodiment illustrated in
[0063] Thus, a representative set of dimensions for the two zones of the implant (
[0064] Cancellous threads, Dmaj=10.5 mm, Dmin=8.5 mm, P=2.75 mm
[0065] Cortical threads, Dmaj=11.0 mm, Dmin=9.5 mm, P=1.75 mm
[0066] Where Dmaj is the major diameter, which is the maximum diameter of the thread. Dmin is the minor diameter, which in effect is the diameter of the body of the shaft in this embodiment. P is the thread pitch. Typical ISO 261 or Unified Thread Standard (UTS) dimensions may be used for the screw thread dimensions.
[0067] In the embodiment of
[0068] Thus, as illustrated in
[0069] The embodiment shown in
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[0071] An alternative embodiment of a fully threaded implant 108 is shown in
[0072] A cross sectional view of implant 108 is shown in
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[0074] End views of the implant 108 are shown in
[0075] The embodiment 102 in
[0076] The embodiment 106 of
[0077] In an embodiment, the implants 100, 102, 106, and 108 may have perforations 160 for bone through-growth (also termed herein fenestrations). In an embodiment, the threads 140, 142, or 144 are interrupted over the fenestrations. In an alternative embodiment, the threads are continuous over the fenestrations. In an embodiment, the fenestrations 160 penetrate completely through the body of the implant latitudinally. In an embodiment, the fenestrations are slots or apertures, elongated in the longitudinal direction of the implant.
[0078] In a further embodiment, the implant may have a hollow core. In an embodiment, the implant may have a solid core, that is, without a central channel 134.
[0079] In an embodiment, the entire implant is fabricated from medically compatible tantalum, titanium, tantalum alloy, or titanium alloy. For example, an appropriate titanium alloy may be titanium 6Al4V and 6Al4V ELI (ASTM Standard F1472, https://www.astm.org/Standards/F1472.htm (see also https://en.wikipedia.org/wiki/Ti-6Al-4V)), which are alloys made with about 6% aluminum and 4% vanadium. An appropriate tantalum alloy may be tantalum alloyed with 2.5% to 10% tungsten, or 40% niobium. These materials are known to have good biocompatibility and match the modulus of elasticity of bone. In an embodiment, the implant may be manufactured from a titanium alloy in accordance with ASTM F136, or where exterior surfaces are coated with medical-grade commercially pure titanium (CP Ti) per ASTM F1580.
[0080] In an embodiment, the implant may be fabricated from a titanium or tantalum material as described above that is also porous, which is known to enhance bone in-growth, for example with pore sizes ranging in 100 to 900 m and with a porosity of 60-65% to mimic cancellous bone. Porosity is a measure of the void (i.e. empty) spaces in a material and is a fraction of the volume of voids expressed as a percentage. Pore sizes of about 600 m have been recommended as optimal for bone ingrowth (N. Taniguchi, et al., Effect of pore size on bone ingrowth into porous titanium implants fabricated by additive manufacturing: An in vivo experiment, Mater Sci Eng C Mater Biol Appl. 2016 February; 59:690-701. doi: 10.1016/j.msec.2015.10.069. Epub 2015 Oct. 28). In an embodiment, the pore sizes may be 300-400 m. Li, G., Wang, L., Pan, W. et al. In vitro and in vivo study of additive manufactured porous Ti6Al4V scaffolds for repairing bone defects. Sci Rep 6, 34072 (2016). https://doi.org/10.1038/srep34072. In an embodiment, any pore size recitation herein may have a tolerance of 50 m. In an embodiment, the pores may have uniform shapes, or have random shapes.
[0081] The combination of fenestrations, surface roughness, HA or TCP coating, and porosity will facilitate bone in-growth which is desirable for fusion of the implants to surrounding bone.
[0082] In use, the implants are preferably implanted using minimally invasive methods. In an exemplary method, there are four principal steps of the surgical procedure. These are: minimally invasive lateral access via dilators and image guidance, joint preparation via drills or currettes, bone graft placement, and implant delivery. Various implant trajectories are possible.
[0083] In one aspect, a method is provided for stabilizing the SI joint by inserting a single or multiple implants from a lateral to medial direction, transverse to the SI joint.
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[0086] In another embodiment, the method for stabilizing the SI includes inserting the implant through an in-line trajectory, namely in a distraction arthrodesis manner in which the implant would enter at the posterior/superior aspect of the joint and advance caudally and in-line with the SI joint, as shown on
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[0089] In an exemplary procedure, a 1.5-2 cm incision is made, and a dilator and guide pin are used to access the ilium and SI joint under fluoroscopic guidance. A cannulated drill is then advanced over the guide pin to create an osseous tunnel through the ilium and/or sacrum. The drillings are collected for use in the bone graft, avoiding the need for direct ICBG harvest. The joint is prepared by removing cartilage and decorticating the joint area surrounding the tunnel, while irrigation and suction are used to extract joint tissue. Approximately 5 cc bone graft, including autologous bone from the drillings, is then packed into the implant.
[0090] Fixation is then achieved with at least one cannulated implant, and one or more additional implants to ensure rotational stability. Final fluoroscopic images are obtained to confirm correct placement, and the deep tissues and skin incision may be infiltrated with bupivacaine and epinephrine for postoperative pain control. Fusion status is typically assessed with CT 12 months after the procedure if indicated.
TABLE-US-00001 Drawings Legend 100 Implant with continuous threads cancellous and cortical 102 Implant with no threads in the center section 106 Implant with cortical threads only, uniform shaft diameter 108 Implant with fluted tip, flared proximal section 120 Implant body (shaft) 122 Implant body (shaft)- cancellous (distal) section 123 Implant body (shaft) - cortical (proximal) section 124 Body transition section 125 Nose (tip) (distal end) of implant 126 Self- drilling tip 127 Teeth (flutes) on distal tip 128 Taper on shaft at distal end 129 Blunt tip 130 Central channel opening at the distal end 132 Central channel opening at the proximal end 133 Internal taper in central channel 134 Central channel 140 Threads 142 Cancellous Threads at the distal end 144 Cortical Threads at the proximal end. 146 Central section with no threads 150 Back (proximal) end 152 Screwdriver socket 154 Flare in proximal section 160 Perforation for bone in-growth 170 Internal threads 200 Ilium 210 Sacrum 220 Sacroiliac joint 230 Inventive implants in position 240 Implant trajectory